Search Results

AQuify Multipurpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting and storing soft (hydrophilic)lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner. AQuify Multipurpose Solution is also indicated for daily protein removal when used with the no rub directions for use.

AQuify Multi-Purpose Solution is a sterile aqueous solution containing dexpanthenol, preserved with polyhexanide 0.0001%. pluronic F127, edetate disodium dehydrate, sorbitol, tromethamine, sodium phosphate dihydrogren, and purified water.

The provided text describes the safety and effectiveness studies for AQuify Multipurpose Solution, comparing it to predicate devices, particularly ReNu Multipurpose Solution. Here's an analysis of the acceptance criteria and study details based on the input:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative "acceptance criteria" in a table format with pass/fail thresholds. Instead, it describes studies and their findings, concluding that AQuify Multipurpose Solution is "substantially equivalent" to the predicate device. The performance is reported in terms of statistical significance and preference compared to the control.

Here's a table summarizing the findings as they relate to implied acceptance:

Study Details

The primary study mentioned for clinical evaluation is a "three-month prospective, randomized, single masked trial."

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated as a number. The text mentions "over 50% of the subjects expressing a preference" by the final visit, suggesting a sizable cohort was involved, but the exact N is not provided.
   • Data Provenance: Prospective. The study was a "three-month prospective, randomized, single masked trial." Country of origin is not specified but implicitly in the USA as it's a 510(k) submission to the FDA.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document describes a clinical trial where subjects reported symptoms and efficacy scores, and an "investigator appraisal" for lens deposits and wetting.
   • Number of Experts: Not specified.
   • Qualifications of Experts: The "investigator" who performed appraisals would likely be an eye care professional (e.g., optometrist or ophthalmologist), but specific qualifications (e.g., years of experience) are not provided. The subjects themselves provided "ground truth" for subjective measures like comfort and dryness.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Adjudication methods like 2+1 or 3+1 are typically for reconciling discrepancies in expert interpretations of images or findings. This study primarily relies on direct subject reporting of subjective measures and investigator appraisal for objective measures.
   • Adjudication Method: Not applicable/Not mentioned. The study design ("single masked trial," "contra-lateral basis") means subjects compared the products on their own eyes, minimizing the need for adjudication of differing subjective experiences. Objective appraisals (e.g., dark field image analysis) would have predefined criteria.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • MRMC Study: No, this was not an MRMC study. This study evaluated the performance of a contact lens solution, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Standalone Performance: Not applicable. This device is a contact lens solution, not an algorithm. Its performance is evaluated through direct use (cleaning, disinfection, clinical comfort/dryness) or laboratory testing (microbiology, water content).

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For Clinical Efficacy/Safety: Subjective self-reported data from study participants (e.g., comfort scores, dryness scores, preferences) and objective investigator appraisal (lens deposits, front surface wetting, dark-field image analysis).
   • For Microbiology/Cleaning/Dehydration: Laboratory standard tests, likely with pre-defined pass/fail criteria from regulatory guidance (e.g., FDA guidance, USP standards).

7. The sample size for the training set:

   • Not applicable. This is a medical device (contact lens solution), not a machine learning model, so there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

Karats Multi-Purpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting, protein removal, and storing soft (hydrophilic) contact lenses as recommended by your eye care practitioner.

Karats Multi-Purpose Solution is a sterile aqueous solution containing sorbitol, tromethamine, pluronic F127, sodium phosphate dihydrogren, edetate disodium dihydrate and preserved with polyhexanide 0.0001%.

The provided document describes the 510(k) summary for "Karats Multipurpose Solution." It details preclinical and clinical studies conducted to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Generally, acceptance criteria for medical devices like contact lens solutions are predefined benchmarks or thresholds the device must meet to be considered safe and effective. While the document mentions meeting standards and demonstrating substantial equivalence, it does not explicitly list quantitative acceptance criteria in a table format. Instead, it describes results and comparisons to a predicate device.

Based on the text, here's an attempt to infer and present the information in a table format, focusing on what was evaluated and the general outcomes:

2. Sample Size for the Test Set and Data Provenance

• Clinical Study (Test Set): The document describes a "one-month prospective, randomized, double masked trial consisting of baseline, two-week, and final one-month visits." It also states, "Subjects compared the test and control products on a contra-lateral basis and were randomized into two treatment groups."
  • Sample Size: The exact number of subjects or eyes included in the clinical study (Karats 257 versus SOLOCare Plus) is not explicitly stated in the provided text. It mentions percentages for visual acuity and relative comparisons of symptoms, deposits, and comfort, but no N value.
  • Data Provenance: The document does not specify the country of origin for the data. It was a prospective clinical trial.

3. Number of Experts Used and Qualifications for Ground Truth

• The document does not provide information regarding the number of experts used to establish ground truth for the test set or their specific qualifications (e.g., "radiologist with 10 years of experience"). For contact lens solution studies, ground truth for clinical observations (like slit lamp findings, corneal staining, deposits) is typically established by the clinical investigators (optometrists/ophthalmologists) participating in the trial, but their specific qualifications or the method of reaching "ground truth" (e.g., independent evaluations) are not detailed here.

4. Adjudication Method for the Test Set

• The document mentions the clinical trial was a "double masked trial," meaning neither the subjects nor the investigators were aware of the treatment assignment. This helps reduce bias in data collection. However, it does not describe a specific adjudication method (e.g., 2+1, 3+1) for resolving discrepancies in clinical observations or interpretations among multiple readers/clinicians, which might not be a standard requirement for this type of device study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done in the context of comparing human readers with and without AI assistance. This study focused on comparing two contact lens solutions in human subjects. The concept of "human readers" and "AI assistance" is not applicable to this submission.

6. Standalone (Algorithm Only) Performance

• Not applicable in the context of AI algorithms. However, in the microbiological section, the language "meets the stand-alone criteria with organic load for disinfection" refers to a laboratory test where the solution's efficacy against microbes is tested independently, without a human "rub" step. This is a "standalone" performance for the chemical solution's disinfectant properties, not for an AI algorithm.

7. Type of Ground Truth Used

• For the clinical study (Karats 257 versus SOLOCare Plus), the ground truth was primarily based on:
  • Subjective Assessments: Patient-reported symptoms, comfort, lens awareness, and preference.
  • Clinical Observations: Visual acuity measurements, slit lamp findings (e.g., corneal staining, presence of deposits) performed by eye care practitioners.
• For preclinical studies (Lens Compatibility, Cytotoxicity, Microbiological), the ground truth was established through:
  • Laboratory Measurements: Quantifiable optical and physical changes in lenses.
  • Standardized Cytotoxicity Assays: Biological response of cells to the solution.
  • Standardized Microbiological Assays: Measuring the reduction of specific microorganisms by the solution.

8. Sample Size for the Training Set

• This device is a contact lens solution, not an AI algorithm. Therefore, the concept of a "training set" for machine learning is not applicable to this submission. The "training" in a broader sense would refer to the development and formulation process of the solution, which is not detailed in terms of sample sizes here.

9. How Ground Truth for the Training Set Was Established

• As mentioned above, the concept of a "training set" and associated ground truth for an AI algorithm is not applicable to this medical device submission.

Ask a specific question about this device